Visceral pleura ring connector

ABSTRACT

A visceral pleura ring connector that may be utilized to anchor and seal the visceral pleura to a conduit or other device entering the lung from a non-native airway. The visceral pleura ring connector may be positioned around the visceral pleura and an insertion device and seal them together without having to make any holes in the pleura. The visceral pleura ring connector may be utilized with a pulmonary pleural stabilizer to hold the visceral pleura of the lung during surgical procedures involving accessing the lung or lungs of a patient directly through the lung and not the native airways.

FIELD OF THE INVENTION

The present invention relates to methods and devices for treatingdiseased lungs including lungs damaged by chronic obstructive pulmonarydisease and emphysema.

BACKGROUND OF THE INVENTION

Chronic obstructive pulmonary disease is a persistent obstruction of theairways caused by chronic bronchitis and pulmonary emphysema. In theUnited States alone, approximately fourteen million people suffer fromsome form of chronic obstructive pulmonary disease and it is in the topten leading causes of death.

Air enters the mammalian body through the nostrils and flows into thenasal cavities. As the air passes through the nostrils and nasalcavities, it is filtered, moistened and raised or lowered toapproximately body temperature. The back of the nasal cavities iscontinuous with the pharynx (throat region); therefore, air may reachthe pharynx from the nasal cavities or from the mouth. Accordingly, ifequipped, the mammal may breathe through its nose or mouth. Generallyair from the mouth is not as filtered or temperature regulated as airfrom the nostrils. The air in the pharynx flows from an opening in thefloor of the pharynx and into the larynx (voice box). The epiglottisautomatically closes off the larynx during swallowing so that solidsand/or liquids enter the esophagus rather than the lower air passagewaysor airways. From the larynx, the air passes into the trachea, whichdivides into two branches, referred to as the bronchi. The bronchi areconnected to the lungs.

The lungs are large, paired, spongy, elastic organs, which arepositioned in the thoracic cavity. The lungs are in contact with thewalls of the thoracic cavity. In humans, the right lung comprises threelobes and the left lung comprises two lobes. Lungs are paired in allmammals, but the number of lobes or sections of lungs varies from mammalto mammal. Healthy lungs, as discussed below, have a tremendous surfacearea for gas/air exchange. Both the left and right lung is covered witha pleural membrane. Essentially, the pleural membrane around each lungforms a continuous sac that encloses the lung. A pleural membrane alsoforms a lining for the thoracic cavity. The space between the pleuralmembrane forming the lining of the thoracic cavity and the pleuralmembranes enclosing the lungs is referred to as the pleural cavity. Thepleural cavity comprises a film of fluid that serves as a lubricantbetween the lungs and the chest wall.

In the lungs, the bronchi branch into a multiplicity of smaller vesselsreferred to as bronchioles. Typically, there are more than one millionbronchioles in each lung. Each bronchiole ends in a cluster of extremelysmall air sacs referred to as alveoli. An extremely thin, single layerof epithelial cells lining each alveolus wall and an extremely thin,single layer of epithelial cells lining the capillary walls separate theair/gas in the alveolus from the blood. Oxygen molecules in higherconcentration pass by simple diffusion through the two thin layers fromthe alveoli into the blood in the pulmonary capillaries. Simultaneously,carbon dioxide molecules in higher concentration pass by simplediffusion through the two thin layers from the blood in the pulmonarycapillaries into the alveoli.

Breathing is a mechanical process involving inspiration and expiration.The thoracic cavity is normally a closed system and air cannot enter orleave the lungs except through the trachea. If the chest wall is somehowcompromised and air/gas enters the pleural cavity, the lungs willtypically collapse. When the volume of the thoracic cavity is increasedby the contraction of the diaphragm, the volume of the lungs is alsoincreased. As the volume of the lungs increase, the pressure of the airin the lungs falls slightly below the pressure of the air external tothe body (ambient air pressure). Accordingly, as a result of this slightpressure differential, external or ambient air flows through therespiratory passageways described above and fills the lungs until thepressure equalizes. This process is inspiration. When the diaphragm isrelaxed, the volume of the thoracic cavity decreases, which in turndecreases the volume of the lungs. As the volume of the lungs decrease,the pressure of the air in the lungs rises slightly above the pressureof the air external to the body. Accordingly, as a result of this slightpressure differential, the air in the alveoli is expelled through therespiratory passageways until the pressure equalizes. This process isexpiration.

Chronic obstructive pulmonary disease is a persistent obstruction of theairways caused by chronic bronchitis and pulmonary emphysema. Chronicbronchitis and acute bronchitis share certain similar characteristics;however, they are distinct diseases. Both chronic and acute bronchitisinvolve inflammation and constriction of the bronchial tubes and thebronchioles; however, acute bronchitis is generally associated with aviral and/or bacterial infection and its duration is typically muchshorter than chronic bronchitis.

In chronic bronchitis, the bronchial tubes secrete too much mucus aspart of the body's defensive mechanisms to inhaled foreign substances.Mucus membranes comprising ciliated cells (hair like structures) linethe trachea and bronchi. The ciliated cells or cilia continuously pushor sweep the mucus secreted from the mucus membranes in a direction awayfrom the lungs and into the pharynx, where it is periodically swallowed.This sweeping action of the cilia functions to keep foreign matter fromreaching the lungs. Foreign matter that is not filtered by the nose andlarynx, as described above, becomes trapped in the mucus and ispropelled by the cilia into the pharynx. When too much mucus issecreted, the ciliated cells may become damaged, leading to a decreasein the efficiency of the cilia to sweep the bronchial tubes and tracheaof the mucus containing the foreign matter. This in turn causes thebronchioles to become constricted and inflamed and the individualbecomes short of breath. In addition, the individual will develop achronic cough as a means of attempting to clear the airways of excessmucus.

Individuals who suffer from chronic bronchitis may develop pulmonaryemphysema. Pulmonary emphysema may be caused by a number of factors,including chronic bronchitis, long term exposure to inhaled irritants,e.g. air pollution, which damage the cilia, enzyme deficiencies andother pathological conditions. Pulmonary emphysema is a disease in whichthe alveoli walls, which are normally fairly rigid structures, aredestroyed. The destruction of the alveoli walls is irreversible. Inpulmonary emphysema, the alveoli of the lungs lose their elasticity, andeventually the walls between adjacent alveoli are destroyed.Accordingly, as more and more alveoli walls are lost, the air exchange(oxygen and carbon dioxide) surface area of the lungs is reduced untilair exchange becomes seriously impaired.

Mucus hyper-secretion and dynamic airway compression are mechanisms ofairflow limitation in chronic obstructive pulmonary disease. Mucushyper-secretion is described above with respect to bronchitis. Dynamicairway compression results from the loss of tethering forces exerted onthe airway due to the reduction in lung tissue elasticity. In otherwords, the breakdown of lung tissue leads to the reduced ability of thelungs to recoil and the loss of radial support of the airways.Consequently, the loss of elastic recoil of the lung tissue contributesto the inability of individuals to exhale completely. The loss of radialsupport of the airways also allows a collapsing phenomenon to occurduring the expiratory phase of breathing. This collapsing phenomenonalso intensifies the inability for individuals to exhale completely. Asthe inability to exhale completely increases, residual volume in thelungs also increases. This then causes the lung to establish in ahyperinflated state. The individual develops dyspnea in which theindividual can only take short shallow breaths. Essentially, air is noteffectively expelled and stale air accumulates in the lungs. Once thestale air accumulates in the lungs, the individual is deprived ofoxygen.

Another aspect of an emphysematous lung is that the communicating flowof air between neighboring air sacs is much more prevalent as comparedto healthy lungs. This phenomenon is known as collateral ventilation.However, since air cannot be expelled from the native airways due to theloss of tissue elastic recoil and radial support of the airways (dynamiccollapse during exhalation), the increase in collateral ventilation doesnot significantly assist an individual in breathing.

There is no cure for pulmonary emphysema, only various treatments,including exercise, drug therapy, such as bronchodilating agents, lungvolume reduction surgery and long term oxygen therapy. Long term oxygentherapy is widely accepted as the standard treatment for hypoxia causedby chronic obstructive pulmonary disease. Typically, oxygen therapy isprescribed using a nasal cannula. There are disadvantages associatedwith using the nasal cannula. Transtracheal oxygen therapy has become aviable alternative to long term oxygen therapy. Transtracheal oxygentherapy delivers oxygen directly to the lungs using a catheter that isplaced through and down the trachea. Bronchodilating drugs only work ona percentage of patients with chronic obstructive pulmonary disease andgenerally only provide short-term relief. Oxygen therapy is impracticalfor the reasons described above, and lung volume reduction surgery is anextremely traumatic procedure that involves removing part of the lung.The long term benefits of lung volume reduction surgery are not fullyknown.

Accordingly, there exists a need for removing trapped gases from adiseased lung or lungs.

SUMMARY OF THE INVENTION

The present invention relates to a device for treating diseased lungs,and more particularly, to a visceral pleura ring connector for sealingthe visceral pleura to a conduit for removing the trapped air from thelung.

The present invention overcomes the limitations in treating diseasesassociated with chronic obstructive pulmonary disorders, such asemphysema and chronic bronchitis, as briefly described above. A longterm oxygen therapy system may be utilized to effectively treat hypoxiacaused by chronic obstructive pulmonary disease. A collateralventilation bypass trap system may be utilized to take advantage of theabove-described collateral ventilation phenomenon to increase theexpiratory flow from a diseased lung or lungs, thereby treating anotheraspect of chronic obstructive pulmonary disease. Various methods may beutilized to determine the location or locations of the diseased tissue,for example, computerized axial tomography or CAT scans, magneticresonance imaging or MRI, positron emission tomograph or PET, and/orstandard X-ray imaging. Essentially, the most collaterally ventilatedarea of the lung or lungs is determined utilizing the scanningtechniques described above. Once this area or areas are located, aconduit or conduits are positioned in a passage or passages that accessthe outer pleural layer of the diseased lung or lungs. The conduit orconduits utilize the collateral ventilation of the lung or lungs andallow the entrapped air to bypass the native airways and be expelled toa containment system outside of the body.

In order for the system to be effective, the components of the systemare preferably sealed to the lung. Accordingly, methods and devices tocreate a chemically and/or mechanically localized pleurodesis of thepresent invention may be utilized to provide the seals required foreffective sealing of the components of the long term oxygen therapysystem and the collateral ventilation bypass trap system as well asother devices requiring pleurodesis.

The present invention is directed to a visceral pleura ring connectorthat may be utilized to anchor and seal the visceral pleura to a conduitor other device entering the lung from a non-native airway. The visceralpleura ring connector may be positioned around the pleura and inserteddevice and seal them together without having to make any holes in thepleura.

In accordance with one aspect, the present invention comprises ananchoring device for a collateral ventilation bypass system comprisingat least one device connected to at least one lung for removing trappedgases in the lung and a removable ring assembly positionable around theat least one device for securing the at least one device to the visceralpleura.

In accordance with one aspect of the invention, a pulmonary pleuralstabilizer may be utilized to hold the visceral pleura of the lungduring surgical procedures involving accessing the lung or lungs of apatient directly through the lung and not the native airways. The deviceallows the lung to be opened while another device is inserted and sealedto the lung. Once the device is inserted, a visceral pleura ringconnector may be positioned around the pleura and the device to receiveand secure the device in place.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other features and advantages of the invention will beapparent from the following, more particular description of preferredembodiments of the invention, as illustrated in the accompanyingdrawings.

FIG. 1 is a diagrammatic representation of a first exemplary embodimentof the long term oxygen therapy system in accordance with the presentinvention.

FIG. 2 is a diagrammatic representation of a first exemplary embodimentof a sealing device utilized in conjunction with the long term oxygentherapy system of the present invention.

FIG. 3 is a diagrammatic representation of a second exemplary embodimentof a sealing device utilized in conjunction with the long term oxygentherapy system of the present invention.

FIG. 4 is a diagrammatic representation of a third exemplary embodimentof a sealing device utilized in conjunction with the long term oxygentherapy system of the present invention.

FIG. 5 is a diagrammatic representation of a fourth exemplary embodimentof a sealing device utilized in conjunction with the long term oxygentherapy system of the present invention.

FIG. 6 is a diagrammatic representation of a second exemplary embodimentof the long term oxygen therapy system in accordance with the presentinvention.

FIG. 7 is a diagrammatic representation of a first exemplary embodimentof a collateral ventilation bypass trap system in accordance with thepresent invention.

FIG. 8 is a diagrammatic representation of a first exemplary embodimentof a localized pleurodesis chemical delivery system.

FIG. 9 is a diagrammatic representation of a second exemplary embodimentof a localized pleurodesis chemical delivery system.

FIGS. 10A-10G are diagrammatic representations of an exemplarymechanical device for producing a chronic local adhesion in accordancewith the present invention.

FIGS. 11A and 11B are diagrammatic representations of an exemplarypulmonary pleural stabilizer in accordance with the present invention.

FIGS. 12A, 12B, 12C and 12D are diagrammatic representations of twoexemplary holding devices in accordance with the present invention.

FIGS. 13A and 13B are diagrammatic representations of an exemplaryvisceral pleura ring connector in accordance with the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Long-Term Oxygen Therapy System

A long term oxygen therapy system and method may be utilized to deliveroxygen directly into the lung tissue in order to optimize oxygentransfer efficiency in the lungs. In other words, improved efficiencymay be achieved if oxygen were to be delivered directly into thealveolar tissue in the lungs. In emphysema, alveoli walls are destroyed,thereby causing a decrease in air exchange surface area. As more alveoliwalls are destroyed, collateral ventilation resistance is lowered.Accordingly, if it can be determined where collateral ventilation isoccurring, then the diseased lung tissue may be isolated and the oxygendelivered to this precise location or locations. Various methods may beutilized to determine the diseased tissue locations, for example,computerized axial tomography or CAT scans, magnetic resonance imagingor MRI, positron emission tomograph or PET, and/or standard X-rayimaging. Once the diseased tissue is located, pressurized oxygen may bedirectly delivered to these diseased areas and more effectively andefficiently forced into the lung tissue for air exchange.

Once the location or locations of the diseased tissue are located,anastomotic openings are made in the thoracic cavity and lung or lungsand one or more oxygen carrying conduits are positioned and sealedtherein. The one or more oxygen carrying conduits are connected to anoxygen source which supplies oxygen under elevated pressure directly tothe diseased portion or portions of the lung or lungs. The pressurizedoxygen essentially displaces the accumulated air and is thus more easilyabsorbed by the alveoli tissue. In addition, the long term oxygentherapy system may be configured in such a way as to provide collateralventilation bypass in addition to direct oxygen therapy. In thisconfiguration, an additional conduit may be connected between the mainconduit and the individual's trachea with the appropriate valvearrangement. In this configuration, stale air may be removed through thetrachea when the individual exhales since the trachea is directly linkedwith the diseased site or sites in the lung via the conduits. The longterm oxygen therapy system improves oxygen transfer efficiency in thelungs thereby reducing oxygen supply requirements, which in turn reducesthe patient's medical costs. The system also allows for improvedself-image, improved mobility, and greater exercise capability and iseasily maintained.

FIG. 1 illustrates a first exemplary long term oxygen therapy system100. The system 100 comprises an oxygen source 102, an oxygen carryingconduit 104 and a one-way valve 106. The oxygen source 102 may compriseany suitable device for supplying filtered oxygen under adjustablyregulated pressures and flow rates, including pressurized oxygen tanks,liquid oxygen reservoirs, oxygen concentrators and the associateddevices for controlling pressure and flow rate e.g. regulators. Theoxygen carrying conduit 104 may comprise any suitable biocompatibletubing having a high resistance to damage caused by continuous oxygenexposure. The oxygen carrying conduit 104 comprises tubing having aninside diameter in the range from about 1/16 inch to about ½ inch andmore preferably from about ⅛ inch to about ¼ inch. The one-way valve 106may comprise any suitable, in-line mechanical valve which allows oxygento flow into the lungs 108 through the oxygen carrying conduit 104, butnot from the lungs 108 back into the oxygen source 102. For example, asimple check valve may be utilized. As illustrated in FIG. 1, the oxygencarrying conduit 104 passes through the lung 108 at the site determinedto have the highest degree of collateral ventilation.

The exemplary system 100 described above may be modified in a number ofways, including the use of an in-line filter. In this exemplaryembodiment, both oxygen and air may flow through the system. In otherwords, during inhalation, oxygen is delivered to the lungs through theoxygen carrying conduit 104 and during exhalation, air from the lungsflow through the oxygen carrying conduit 104. The in-line filter wouldtrap mucus and other contaminants, thereby preventing a blockage in theoxygen source 102. In this exemplary embodiment, no valve 106 would beutilized. The flow of oxygen into the lungs and the flow of air from thelungs is based on pressure differentials.

In order for the exemplary long term oxygen therapy system 100 tofunction, an air-tight seal is preferably maintained where the oxygencarrying conduit 104 passes through the thoracic cavity and lung. Thisseal is maintained in order to sustain the inflation/functionality ofthe lungs. If the seal is breached, air can enter the cavity and causethe lungs to collapse as described above.

A method to create this seal comprises forming adhesions between thevisceral pleura of the lung and the inner wall of the thoracic cavity.This may be achieved using either chemical methods, including irritantssuch as Doxycycline and/or Bleomycin, surgical methods, includingpleurectomy or horoscope talc pleurodesis, or radiotherapy methods,including radioactive gold or external radiation. All of these methodsare known in the relevant art for creating pleurodesis. With a sealcreated at the site for the ventilation bypass, an intervention may besafely performed without the danger of creating a pneumothorax of thelung.

Similarly to ostomy pouches or bags, the oxygen carrying conduit 104 maybe sealed to the skin at the site of the ventilation bypass. In oneexemplary embodiment, illustrated in FIG. 2, the oxygen carrying conduit104 may be sealed to the skin of the thoracic wall 202 utilizing anadhesive 204. As illustrated, the oxygen carrying conduit 104 comprisesa flange 200 having a biocompatible adhesive coating 204 on the skincontacting surface. The biocompatible adhesive 204 would provide a fluidtight seal between the flange 200 and the skin or epidermis of thethoracic wall 202. In a preferred embodiment, the biocompatible adhesive204 provides a temporary fluid tight seal such that the oxygen carryingconduit 104 may be disconnected from the ventilation bypass site. Thiswould allow for the site to be cleaned and for the long term oxygentherapy system 100 to undergo periodic maintenance.

FIG. 3 illustrates another exemplary embodiment for sealing the oxygencarrying conduit 104 to the skin of the thoracic wall 202 at the site ofthe ventilation bypass. In this exemplary embodiment, a coupling plate300 is sealed to the skin at the site of the ventilation bypass by abiocompatible adhesive coating 204 or any other suitable means. Theoxygen carrying conduit 104 is then connected to the coupling plate 300by any suitable means, including threaded couplings and locking rings.The exemplary embodiment also allows for clearing of the site andmaintenance of the system 100.

FIG. 4 illustrates yet another exemplary embodiment for sealing theoxygen carrying conduit 104 to the skin of the thoracic wall 202 at thesite of the ventilation bypass. In this exemplary embodiment, balloonflanges 400 may be utilized to create the seal. The balloon flanges 400may be attached to the oxygen carrying conduit 104 such that in thedeflated state, the oxygen carrying conduit 104 and one of the balloonflanges passes through the ventilation bypass anastomosis. The balloonflanges 400 are spaced apart a sufficient distance such that the balloonflanges remain on opposite sides of the thoracic wall 202. Wheninflated, the balloons expand and form a fluid tight seal by sandwichingthe thoracic wall. Once again, this exemplary embodiment allows for easyremoval of the oxygen carrying conduit 104.

FIG. 5 illustrates yet another exemplary embodiment for sealing theoxygen carrying conduit 104 to the skin of the thoracic wall 202 at thesite of the ventilation bypass. In this exemplary embodiment, a singleballoon flange 500 is utilized in combination with a fixed flange 502.The balloon flange 500 is connected to the oxygen carrying conduit 104in the same manner as described above. In this exemplary embodiment, theballoon flange 500, when inflated, forms the fluid tight seal. The fixedflange 502, which is maintained against the skin of the thoracic wall202, provides the structural support against which the balloon exertspressure to form the seal.

Collateral Ventilation Bypass System

The above-described long term oxygen therapy system may be utilized toeffectively treat hypoxia caused by chronic obstructive pulmonarydisease; however, other means may be desirable to treat other aspects ofthe disease. A collateral ventilation bypass trap system utilizes theabove-described collateral ventilation phenomenon to increase theexpiratory flow from a diseased lung or lungs, thereby treating anotheraspect of chronic obstructive pulmonary disease. Essentially, the mostcollaterally ventilated area of the lung or lungs is determinedutilizing the scanning techniques described above. Once this area orareas are located, a conduit or conduits are positioned in a passage orpassages that access the outer pleural layer of the diseased lung orlungs. The conduit or conduits utilize the collateral ventilation of thelung or lungs and allows the entrapped air to bypass the native airwaysand be expelled to a containment system outside of the body.

If an individual has difficulty exhaling and requires additional oxygen,collateral ventilation bypass may be combined with direct oxygentherapy. FIG. 6 illustrates an exemplary embodiment of a collateralventilation bypass/direct oxygen therapy system 600. The system 600comprises an oxygen source 602 (with potential filter), an oxygencarrying conduit 604 having two branches 606 and 608, and a controlvalve 610. The oxygen source 602 and oxygen carrying conduit 604 maycomprise components similar to the above-described exemplary embodimentillustrated in FIG. 1.

In this exemplary embodiment, as shown in FIG. 6, when the individualinhales, the valve 610 is open and oxygen flows into the lung 612 andinto the bronchial tube 614. In an alternate exemplary embodiment, thebranch 608 may be connected to the trachea 616. Accordingly, duringinhalation oxygen flows to the diseased site in the lung or lungs and toother parts of the lung through the normal bronchial passages. Duringexhalation, the valve 610 is closed so that no oxygen is delivered andair in the diseased portion of the lung may flow from the lung 612,through one branch 606 and into the second branch 608 and finally intothe bronchial tube 614. In this manner, stale air is removed and oxygenis directly delivered. Once again, as described above, the flow ofoxygen and air is regulated by simple pressure differentials. A sealedjoint 607 is provided at the end of branch 606, and a sealed joint 609is provided at the end of branch 608. The connection and sealing of theoxygen carrying conduit 604 and branches 606, 608 to the lung 612 andbronchial tube 614 may be made in a manner similar to that describedabove.

FIG. 7 illustrates a first exemplary collateral ventilation bypass trapsystem 700. The system 700 comprises a trap 702, an air carrying conduit704 and a filter/one-way valve 706. The air carrying conduit 704 createsa fluid communication between an individual's lung 708 and the trap 702through the filter/one-way valve 706. It is important to note thatalthough a single conduit 704 is illustrated, multiple conduits may beutilized in each lung 708 if it is determined that there are more thanone area of high collateral ventilation.

The trap 702 may comprise any suitable device for collecting dischargefrom the individual's lung or lungs 708. Essentially, the trap 702 issimply a containment vessel for temporarily storing discharge from thelungs, for example, mucous and other fluids that may accumulate in thelungs. The trap 702 may comprise any suitable shape and may be formedfrom any suitable metallic or non-metallic materials. Preferably, thetrap 702 should be formed from a lightweight, non-corrosive material. Inaddition, the trap 702 should be designed in such a manner as to allowfor effective and efficient cleaning. In one exemplary embodiment, thetrap 702 may comprise disposable liners that may be removed when thetrap 702 is full. The trap 702 may be formed from a transparent materialor comprise an indicator window so that it may be easily determined whenthe trap 702 should be emptied or cleaned. A lightweight trap 702increases the patient's mobility.

The filter/one-way valve 706 may be attached to the trap 702 by anysuitable means, including threaded fittings or compression type fittingscommonly utilized in compressor connections. The filter/one-way valve706 serves a number of functions. The filter/one-way valve 706 allowsthe air from the individual's lung or lungs 708 to exit the trap 702while maintaining the fluid discharge and solid particulate matter inthe trap 702. This filter/one-way valve 706 would essentially maintainthe pressure in the trap 702 below that of the pressure inside theindividual's lung or lungs 708 so that the flow of air from the lungs708 to the trap 702 is maintained in this one direction. The filterportion of the filter/one-way valve 706 may be designed to captureparticulate matter of a particular size which is suspended in the air,but allows the clean air to pass therethrough and be vented to theambient environment. The filter portion may also be designed in such amanner as to reduce the moisture content of the exhaled air.

The air carrying conduit 704 connects the trap 702 to the lung or lungs708 of the patient through the filter/one-way valve 706. The aircarrying conduit 704 may comprise any suitable biocompatible tubinghaving a resistance to the gases contained in air. The air carryingconduit 704 comprises tubing having an inside diameter in the range fromabout 1/16 inch to about ½ inch, and more preferably from about ⅛ inchto about ¼ inch. The filter/one-way valve 706 may comprise any suitablevalve which allows air to flow from the lung or lungs 708 through theair carrying conduit 704, but not from the trap 702 back to the lungs708. For example, a simple check valve may be utilized. The air carryingconduit 704 may be connected to the filter/one-way valve 706 by anysuitable means. Preferably, a quick release mechanism is utilized sothat the trap may be easily removed for maintenance.

As illustrated in FIG. 7, the air carrying conduit 704 passes throughthe lung 708 at the site determined to have the highest degree ofcollateral ventilation. If more than one site is determined, multipleair carrying conduits 704 may be utilized. The connection of multipleair carrying conduits 704 to the filter/one-way valve 706 may beaccomplished by any suitable means, including an octopus device similarto that utilized in scuba diving regulators.

The air carrying conduit 704 is preferably able to withstand and resistcollapsing once in place. Since air will travel through the conduit 704,if the conduit is crushed and unable to recover, the effectiveness ofthe system is diminished. Accordingly, a crush recoverable material maybe incorporated into the air carrying conduit 704 in order to make itcrush recoverable. Any number of suitable materials may be utilized. Forexample, Nitinol incorporated into the conduit 704 will give the conduitcollapse resistance and collapse recovery properties.

Expandable features at the end of the conduit 704 may be used to aid inmaintaining contact and sealing the conduit 704 to the lung pleura.Nitinol incorporated into the conduit 704 will provide the ability todeliver the conduit 704 in a compressed state and then deployed in anexpanded state to secure it in place. Shoulders at the end of theconduit may also provide a mechanical stop for insertion and an area foran adhesive/sealant to join as described in detail subsequently.

In order for the exemplary collateral ventilation bypass trap system 700to function, an air-tight seal is preferably maintained where the aircarrying conduit 704 passes through the thoracic cavity and lungs 708. Asealed joint 705 is provided at the end of conduit 704. This seal ismaintained in order to sustain the inflation/functionality of the lungs.If the seal is breached, air can enter the cavity and cause the lungs tocollapse. One exemplary method for creating the seal comprises formingadhesions between the visceral pleura of the lung and the inner wall ofthe thoracic cavity. This may be achieved using either chemical methods,including irritants such as Doxycycline and/or Bleomycin, surgicalmethods, including pleurectomy or thorascopic talc pleurodesis, orradiotherapy methods, including radioactive gold or external radiation.All of these methods are known in the relevant art for creatingpleurodesis. In another alternate exemplary embodiment, a sealed jointbetween the air carrying conduit 704 and the outer pleural layerincludes using various glues to help with the adhesion/sealing of theair carrying conduit 704. Currently, Focal Inc. markets a sealantavailable under the trade name FOCAL/SEAL-L which is indicated for useon a lung for sealing purposes. Focal/Seal-L is activated by light inorder to cure the sealant. Another seal available under the trade nameTHOREX, which is manufactured by Surgical Sealants Inc., is currentlyconducting a clinical trial for lung sealing indications. Thorex is atwo-part sealant that has a set curing time after the two parts aremixed.

The creation of the opening in the chest cavity may be accomplished in anumber of ways. For example, the procedure may be accomplished using anopen chest procedure, sternotomy or thoracotomy. Alternately, theprocedure may be accomplished using a laparoscopic technique, which isless invasive. Regardless of the procedure utilized, the seal should beestablished while the lung is at least partially inflated in order tomaintain a solid adhesive surface. The opening may then be made afterthe joint has been adequately created between the conduit component andthe lung pleural surface. The opening should be adequate incross-sectional area in order to provide sufficient decompression of thehyperinflated lung. This opening, as stated above, may be created usinga number of different techniques such as cutting, piercing, dilating,blunt dissection, radio frequency energy, ultrasonic energy, microwaveenergy, or cryoblative energy.

The air carrying conduit 704 may be sealed to the skin at the site byany of the means and methods described above with respect to the oxygencarrying conduit 704 and illustrated in FIGS. 2 through 5.

In operation, when an individual exhales, the pressure in the lungs isgreater than the pressure in the trap 702. Accordingly, the air in thehighly collateralized areas of the lung will travel through the aircarrying conduit 704 to the trap 702. This operation will allow theindividual to more easily and completely exhale.

Localized Pleurodesis Systems and Method

In the above-described exemplary apparatus and procedure for increasingexpiratory flow from a diseased lung using the phenomenon of collateralventilation, there will be an optimal location to penetrate the outerpleura of the lung to access the most collaterally ventilated area orareas of the lung. As described above, there are a variety of techniquesto locate the most collaterally ventilated area or areas of the lungs.Since a device or component of the apparatus functions to allow the airentrapped in the lung to bypass the native airways and be expelledoutside of the body, it is particularly advantageous to provide anair-tight seal of the parietal (thoracic wall) and visceral (lung)pleurae. If a proper air-tight seal is not created between the device,parietal and visceral pleurae, then a pneumothorax (collapsed lung) mayoccur. Essentially, in any circumstance where the lung is punctured anda device inserted, an air-tight seal should preferably be maintained.

One way to achieve an air-tight seal is through pleurodesis, i.e. anobliteration of the pleural space. There are a number of pleurodesismethods, including chemical, surgical and radiological. In chemicalpleurodesis, an agent such as tetracycline, doxycycline, bleomycin ornitrogen mustard may be utilized. In surgical pleurodesis, a pleurectomyor a thorascopic talc procedure may be performed. In radiologicalprocedures, radioactive gold or external radiation may be utilized. Inthe present invention, chemical pleurodesis is utilized. Exemplarymethods for creating the seal comprises forming adhesions between thevisceral pleura of the lung and the inner wall of the thoracic cavityusing chemical methods, including irritants such as Doxycycline and/orBleomycin, surgical methods, including pleurectomy or thorascopic talcpleurodesis. In another alternate exemplary embodiment, a sealed jointbetween the air carrying conduit 704 and the outer pleural layerincludes using various glues to help with the adhesion/sealing of theair carrying conduit 704. Currently, Focal Inc. markets a sealantavailable under the trade name FOCAL/SEAL-L which is indicated for useon a lung for sealing purposes. Focal/Seal-L is activated by light inorder to cure the sealant. Another seal available under the trade nameTHOREX, which is manufactured by Surgical Sealants Inc., is currentlyconducting a clinical trial for lung sealing indications. Thorex is atwo-part sealant that has a set curing time after the two parts aremixed.

Exemplary devices and methods for delivering a chemical(s) or agent(s)in a localized manner for ensuring a proper air-tight seal of theabove-described apparatus is described below. The chemical(s), agent(s)and/or compound(s) are used to create a pleurodesis between the parietaland visceral pleura so that a component of the apparatus may penetratethrough the particular area and not result in a pneumothorax. There area number of chemical(s), agent(s) and/or compound(s) that may beutilized to create a pleurodesis in the pleural space. The chemical(s),agent(s) and/or compound(s) include talc, tetracycline, doxycycline,bleomycin and minocycline.

In one exemplary embodiment, a modified drug delivery catheter may beutilized to deliver chemical(s), agent(s) and/or compound(s) to alocalized area for creating a pleurodesis in that area. In thisexemplary embodiment, the pleurodesis is formed and then the conduit704, as illustrated in FIG. 7, is positioned in the lung 708 through thearea of the pleurodesis. The drug delivery catheter provides a minimallyinvasive means for creating a localized pleurodesis. Referring to FIG.8, there is illustrated an exemplary embodiment of a drug deliverycatheter that may be utilized in accordance with the present invention.Any number of drug delivery catheters may be utilized. In addition, thedistal tip of the catheter may comprise any suitable size, shape orconfiguration thereby enabling the formation of a pleurodesis having anysize, shape or configuration.

As illustrated in FIG. 8, the catheter 800 is inserted into the patientsuch that the distal end 802 is positioned in the pleural space 804between the thoracic wall 808 and the lung 806. In the illustratedexemplary embodiment, the distal end 802 of the catheter 800 comprises asubstantially circular shape that would allow the chemical(s), agent(s)and/or compound(s) to be released towards the inner diameter of thesubstantially circular shape as indicated by arrows 810. The distal end802 of the catheter 800 comprising a plurality of holes or openings 812through which the chemical(s), agent(s) and/or compound(s) are released.As stated above, the distal end 802 may comprise any suitable size,shape or configuration. Once the chemical(s), agent(s) and/orcompound(s) are delivered, the catheter 800 may be removed to allow forimplantation of the conduit 704 (FIG. 7). Alternately, the catheter 800may be utilized to facilitate delivery of the conduit 704.

The distal end or tip 802 of the catheter 800 should preferably maintainits desired size, shape and/or configuration once deployed in thepleural space. This may be accomplished in a number of ways. Forexample, the material forming the distal end 802 of the catheter 800 maybe selected such that it has a certain degree of flexibility forinsertion of the catheter 800 and a certain degree of shape memory suchthat it resumes its original or programmed shape once deployed. Anynumber of biocompatible polymers with these properties may be utilized.In an alternate embodiment, another material may be utilized. Forexample, a metallic material having shape memory characteristics may beintegrated into the distal end 802 of the catheter 800. This metallicmaterial may include Nitinol or stainless steel. In addition, themetallic material may be radiopaque or comprise radiopaque markers. Byhaving a radiopaque material or radiopaque markers, the catheter 800 maybe viewed under x-ray fluoroscopy and aid in determining when thecatheter 800 is at the location of the highest collateral ventilation.

In another alternate exemplary embodiment, a local drug delivery devicemay be utilized to deliver the pleurodesis chemical(s), agent(s) and/orcompound(s). In this exemplary embodiment, the pleurodesis is formed andthen the conduit 704, as illustrated in FIG. 7, is positioned in thelung 708 through the pleurodesis. In this exemplary embodiment,chemical(s), agent(s) and/or compound(s) may be affixed to animplantable medical device. The medical device is then implanted in thepleural cavity at a particular site and the chemical(s), agent(s) and/orcompound(s) are released therefrom to form or create the pleurodesis.

Any of the above-described chemical(s), agent(s) and/or compound(s) maybe affixed to the medical device. The chemical(s), agent(s) and/orcompound(s) may be affixed to the medical device in any suitable manner.For example, the chemical(s), agent(s) and/or compound(s) may be coatedon the device utilizing any number of well known techniques including,spin coating, spraying or dipping, they may be incorporated into apolymeric matrix that is affixed to the surface of the medical device,they may be impregnated into the outer surface of the medical device,they may be incorporated into holes or chambers in the medical device,they may be coated onto the surface of the medical device and thencoated with a polymeric layer that acts as a diffusion barrier forcontrolled release of the chemical(s), agent(s) and/or compound(s), theymay be incorporated directly into the material forming the medicaldevice, or any combination of the above-described techniques. In anotheralternate embodiment, the medical device may be formed from abiodegradable material which elutes the chemical(s), agent(s) and/orcompound(s) as the device degrades.

The implantable medical device may comprise any suitable size, shapeand/or configuration, and may be formed using any suitable biocompatiblematerial. FIG. 9 illustrates one exemplary embodiment of an implantablemedical device 900. In this embodiment, the implantable medical device900 comprises a substantially cylindrical disk 900. The disk 900 ispositioned in the pleural space 902 between the thoracic wall 904 andthe lung 906. Once in position, the disk 900 elutes or otherwisereleases the chemical(s), agent(s) and/or compound(s) that form thepleurodesis. The release rate may be precisely controlled by using anyof the various techniques described above, for example, a polymericdiffusion barrier. Also, as stated above, the disk 900 may be formedfrom a biodegradable material that elutes the chemical(s), agent(s)and/or compound(s) as the disk 900 itself disintegrates or dissolves.Depending upon the material utilized in the construction of the disk900, a non-biodegradable disk 900 may or may not require removal fromthe pleural cavity 902 once the pleurodesis is formed. For example, itmay be desirable that the disk 900 is a permanent implant that becomesintegral with the pleurodesis.

As described in the previous exemplary embodiment, the disk 900 maycomprise a radiopaque marker or be formed from a radiopaque material.The radiopaque marker or material allows the disk 900 to be seen underfluoroscopy and then positioned accurately.

In yet another alternate exemplary embodiment, the fluid characteristicsof the chemical(s), agent(s) and/or compound(s) may be altered. Forexample, the chemical(s), agent(s) and/or compound(s) may be made moreviscous. With a more viscous chemical agent and/or compound, there wouldbe less chance of the chemical, agent and/or compound moving from thedesired location in the pleural space. The chemical(s), agent(s) and/orcompound(s) may also comprise radiopaque constituents. Making thechemical(s), agent(s) and/or compounds radiopaque would allow theconfirmation of the location of the chemical(s), agent(s) and/orcompound(s) with regard to the optimal location of collateralventilation. The chemical(s), agent(s) and/or compound(s) as modifiedabove may be utilized in conjunction with standard chemical pleurodesisdevices and processes or in conjunction with the exemplary embodimentsset forth above.

In an alternate exemplary embodiment, an implantable structure incombination with a chemical agent and/or a therapeutic agent may beutilized to create a localized area where the visceral and parietalpleura of the lung are fused together. In this exemplary embodiment, alocalized pleurodesis may be created utilizing either or both amechanical component and a chemical component. The purpose of thechemical component is to provide an acute adhesion between the parietaland visceral pleura, while the mechanical component is utilized toprovide a chronic adhesion. In other words, the acute adhesion providedby the chemical adhesive would provide enough stability at the implantlocation on the lung to allow for the mechanical component to create achronic adhesion. The combination of a chemical adhesive with a tissuegrowth promoting material in a specific area of the lung would promote awell-controlled localized pleurodesis reaction.

FIGS. 10A, 10B and 10C illustrate a first exemplary mechanical device1000 for providing a chronic adhesion. FIG. 10A shows a close up view ofthe sectional view of mechanical device 1000 shown in FIG. 10B. FIG. 10Cshows a cutaway view of the mechanical device 1000 shown in FIG. 10B onthe surface of lung 1022. As illustrated, the mechanical device 1000comprises a mesh 1002 that may be formed out of any suitablebiocompatible material. For example, the mesh 1002 may comprise ametallic material, a polymeric material and/or a ceramic material.Primary variations of this material may be bio-resorbable ornon-resorbable materials that promote tissue growth. Any type of meshmay be utilized including hernia repair meshes, laparoscopic meshes andsurgical meshes. The mesh 1002 may be inserted between the parietal 1005and visceral 1007 pleura at the desired location by any suitable meansas set forth below. The mesh 1002 may be simply positioned or secured inplace by any number of suitable means. In a preferred exemplaryembodiment, the mechanical device is secured in such a manner thatensures the apposition of the device to either and/or both the visceralpleura 1007 and parietal pleura 1005. As shown in FIG. 10G, this may beaccomplished by a percutaneous application of a chemical adhesive 1010after the lung is inflated to allow for a chemical agent to form anacute adhesion between the visceral pleura 1007 and parietal pleura1005. The chemical adhesive 1010 may include fibrin backed adhesive,cyanoacrylate bond adhesive or aldehyde bond adhesive. Alternately, asshown in FIG. 10D, a suture 1004 may be threaded into the device andpulled along with the visceral pleura against the parietal pleura of thethoracic wall.

Radiological markers may be incorporated into the device 1000 therebyincreasing its radiopacity under fluoroscopy. Essentially, this wouldensure that in follow-up examinations, the exact location of where thelocalized pleurodesis has grown would be easy to find. These markers maybe incorporated into the device 1000 in any number of suitable ways. Forexample, as shown in FIG. 10F, a wire ring 1006 may be woven into thespot of the tissue growth promoting material of the mesh. Alternately,as shown in FIG. 10E, radiological fibers 1008 may be incorporated intothe tissue promoting fibers of the mesh 1002. In yet another alternateexemplary embodiment, a radiological chemical adhesive may be utilizedas shown in FIG. 10G.

The delivery of the device 1000 may be approached utilizing any numberof acceptable procedures. In one exemplary embodiment, a thoracotomyprocedure to open the thoracic cavity may be performed, and the device1000 placed directly in the location. In another exemplary embodiment, aminimally invasive approach using a cannula or such like device may beutilized to percutaneously access the thoracic cavity. The device 1000could then be entirely delivered via a delivery system through thecannula or sheath.

Current pleurodesis procedures look to create adhesion between theentire lung and the thoracic wall, effectively sealing off any thoraciccavity spaces. The device of the present invention allows for a smallcontrolled local pleurodesis to form, thereby reducing potentiallypainful side effects and minimize pleural adhesions for subsequentthoracic interventions. Additionally, due to the dynamic nature betweenthe lung and thoracic wall, it may be difficult to create a chroniclocal pleurodesis without the help of a clinical adhesive to provideacute stability to the location of intent.

Anastomosis Devices and Methods

For any of the above-described devices that require access to apatient's lung or lungs via surgically attaching a conduit to the lungor lungs and not through a native airway, the visceral pleura must beproperly attached to the conduit in order to properly seal around theconduit. A technique that may be utilized is to gather and attach thevisceral pleura around the conduit using a purse-string suture orsimilar technique. This technique, however, requires the handling of thepleura in order to provide a counterforce on the pleura as the conduitis being positioned in the lung. In addition, what makes this techniquemore difficult is as soon as an access is made through the pleura forthe conduit, the lung will immediately leak air and collapse to asmaller size. Therefore, providing a counterforce to insert a conduit orother device described herein through the access in the lung becomeseven more vital.

The visceral pleura of the lung are thin and somewhat fragile.Manipulation of the pleura using surgical instruments such as forceps orhemostats may create a break in the pleura. It is often difficult toseal the leak that will follow and the leak will typically result in apneumothorax or a collapsed lung. In an emphysematous lung where thepatient is already compromised with the inability to breath, apneumothorax may potentially lead to serious complications, includingdeath.

Although there are devices that resect lung tissue and help seal itthereafter, there are currently no devices that enter the lung throughthe visceral pleura. Lung resection and buttressing devices do not needto rely on stabilization and counterforce. Accordingly, the presentinvention is directed to a device that would provide the ability toinsert a conduit or other device in the lung with a significantlydecreased chance of injuring the lung if conventional surgical tools areutilized. Essentially, if a device could stabilize the visceral pleuraand provide the counterforce without damaging the pleura, the procedureof inserting the device in the lung could become easier, faster and lessconducive to injuring the pleura.

In accordance with one exemplary embodiment, a vacuum assist device 1102may be utilized to hold the pleura while a conduit or other device isbeing positioned in the lung. Referring to FIG. 11A, there isillustrated an inflated lung 1100A and a deflated lung 1100B and anaccess point 1100C. Illustrated in FIG. 11B is a vacuum assist device1102 which comprises a substantially disc-like structure or removableholding device 1104 illustrated in FIGS. 12A, 12B, 12C and 12D, thatexerts a vacuum force 1200 on the visceral pleura 1101 in contacttherewith and an insertion envelope 1106 through which a conduit orother device may be inserted. Although any shape device may be utilized,for ease of explanation a substantially disc like structure isillustrated.

As illustrated in FIGS. 11B, 12A, 12B, 12C and 12D the disc-likestructure 1104 preferably has one substantially flat surface 1202 thatmakes contact with the visceral pleura 1101. This flat surface has oneor more openings through which a vacuum force that is created by anexternal source (not illustrated) is transmitted to the visceral pleura.This gentle vacuum force, in the range from about 10 mm Hg to about 450mm Hg is preferably evenly distributed over the substantially flatsurface and gently pulls the visceral pleura 1101 into contact with thesubstantially flat surface 1202. In one exemplary embodiment,illustrated in FIG. 12A the disc like structure 1104 comprises a slitlike opening 1108 that forms the envelope 1106. In an alternateexemplary embodiment, illustrated in FIG. 12B, the disc like structure1104 comprises a two piece structure that when connected together formsthe envelope 1106. The disc like structure 1104 may be formed from anysuitable biocompatible material that will not damage the visceral pleuraand is easily removed from the pleural space when the vacuum is cut off.

Once the vacuum assist device 1102 is inserted and placed into contactwith the visceral pleura 1101, the vacuum is started and draws and holdsthe visceral pleura 1101 in place while the conduit 1204 or other deviceis inserted through the envelope 1106. The vacuum assist device 1102maintains the counter-pressure for insertion and sealing withoutdamaging the lung tissue. When the seal is created, the vacuum is cutoff and the device 1102 is removed.

The vacuum pressure or negative pressure may be created in a variety ofways. For example, surgical sites are typically equipped with vacuumdevices that may be regulated to draw a negative pressure in the desiredrange. A simple pressure regulator or vacuum regulator may be connectedbetween two vacuum sources and the device 1102 by any suitable means. Inalternate exemplary embodiments, the device 1102 may comprise a vacuumpump and regulator. The vacuum pump may use hospital power or be aself-contained battery power unit.

As described above, once a device such as a conduit 1204 is insertedinto the lung, the device must be sealed to the lung tissue. Also asdescribed above is the purse-string suture that may be utilized togather and attach the visceral pleura 1101 around the conduit 1204 orother device to create the seal. While this technique and other similartechniques may be utilized to create a seal, when the suture is pushedthrough the visceral pleura 1101 and around the conduit 1204, it willinevitably leave small holes or tears through the pleura which mayeventually lead to leaks. Accordingly, it would be advantageous to sealthe visceral pleura 1101 around the conduit 1204 without having to makeany holes or tears through or in the visceral pleura 1101. If thevisceral pleura 1101 were to be gathered around the conduit or otherdevice, it would provide the accessibility to use a ring-type device tosecure the gathered pleura around the conduit or other medical device.

Referring to FIGS. 13A and 13B, there is illustrated an exemplaryvisceral pleural ring connector 1300 in accordance with the presentinvention. As illustrated, the visceral pleural ring connector 1300 issimply placed around the gathered pleura 1302 which is gathered aroundthe conduit 1304. Any suitable biocompatible material may be utilized inconstructing the visceral pleural ring connector 1300. The visceralpleural ring connector 1300 may be constructed from any number ofsuitable materials, including superelastic materials such as nickeltitanium alloys and bioabsorbable materials such as polyglycolic acid.If a superelastic material, such as a nickel titanium alloy, isutilized, the material may be programmed to be delivered at a firstexpanded diameter and, when released from a delivery device, allowed tocontract to a second smaller diameter that snuggly holds the gatheredvisceral pleura 1302 to the conduit 1304. It is important that the ring1300 not fit too tight so as to avoid potential damage to the visceralpleura 1302. Alternately, the ring 1300 may be delivered in itscontracted form, expanded and positioned over the gathered visceralpleura 1302 and then allowed to contract to its programmed size. Inother exemplary embodiments that use other than superelastic materials,various means may be incorporated into the ring structure 1300 fordelivery and securing. For example, the ring 1300 may comprise a splitring design wherein the ring 1300 may be opened like a chain link,placed around the gathered visceral pleura and then manually closed tocreate a snug fit. In other exemplary embodiments, various self-lockingstructures may be incorporated into the ring structure 1300. Forexample, a ratchet mechanism may be utilized to tighten the ring 1300around the gathered visceral pleura 1302. It is important to note thatany type of locking or tightening mechanisms may be utilized.

In an alternate exemplary embodiment, one or more agents may be affixedto the ring 1300. The one or more agents may be directly affixed to thesurface of the ring 1300, incorporated into a polymeric vehicle and thenaffixed to the surface of the ring 1300, incorporated into channels orholes in the ring 1300 or incorporated into the bulk material formingthe ring 1300. The one or more agents may include chemicals to promotethe pleurodesis reaction between the parietal pleura (inner thoracicwall) and the visceral pleura (lung). The pleurodesis is a key componentto the chronic success of the procedure. The pleurodesis reaction willallow for the anastomosis to chronically exist without the danger ofpneumothorax.

Although shown and described in what is believed to be the mostpractical and preferred embodiments, it is apparent that departures fromspecific designs and methods described and shown will suggest themselvesto those skilled in the art and may be used without departing from thespirit and scope of the invention. The present invention is notrestricted to the particular constructions described and illustrated,but should be constructed to cohere with all modifications that may fallwithin the scope of the appended claims.

1. A device for treating a lung of a patient through an aperture in avisceral membrane of the lung, the device comprising: a tubular memberadapted for insertion into parenchymal tissue of the lung through thevisceral membrane of the lung; a securing device positioned around thetubular member; an annular gap between the securing device and thetubular member adapted to receive a portion of the visceral membranesurrounding the aperture; and the securing device configured such that,with a portion of the visceral membrane received in the annular gap, thesecuring device is adapted to radially compress the visceral membranebetween the securing device and the tubular member and thereby securethe visceral membrane between the securing device and the tubularmember.
 2. The device of claim 1, wherein said securing device isadapted to create an airtight seal between the lung and the tubularmember.
 3. The device of claim 1, wherein said securing device is a ringthat can be positioned snugly about the tubular member.
 4. The device ofclaim 1, wherein said securing device comprises a superelastic material.5. The device of claim 1, wherein said securing device comprises abioabsorbable material.
 6. The device of claim 1, wherein said securingdevice comprises polyglycolic acid.
 7. The device of claim 1 whereinsaid securing device is a ring that is manually snugly fit about aportion of the visceral membrane received in the annular gap.
 8. Thedevice of claim 1 wherein said securing device is a split ring that ismanually snugly fit about a portion of the visceral membrane received inthe annular gap.
 9. The device of claim 1 wherein said securing deviceis self-locking
 10. The device of claim 1 wherein said securing deviceincludes a ratchet mechanism that is used to tighten the securing deviceto compress a portion of the visceral membrane received in the annulargap.
 11. The device of claim 1 including an agent provided with thesecuring device, wherein said agent promotes a pleurodesis reaction. 12.The device of claim 11 wherein said agent is one of incorporated intothe securing device, provided on the surface of the securing device, andprovided in channels of the securing device.
 13. The device of claim 1wherein said securing device comprises a shape memory material.
 14. Thedevice of claim 1 wherein said securing device comprises a shape memorymaterial, and wherein said securing device is implanted with a firstexpanded diameter and once implanted contracts to a smaller diameter tocompress the visceral membrane between the securing device and thetubular member.
 15. The device of claim 1 wherein: said securing deviceis implanted by expanding the securing device from a contracted diameterto a larger diameter; the securing device being adapted such that with aportion of the visceral membrane received in the annular gap, thesecuring device contracts from the larger diameter to the contracteddiameter to compress the visceral membrane between the securing deviceand the tubular member and thereby secure the visceral membrane betweenthe securing device and the tubular member.
 16. A device for treating alung of a patient through an aperture in a visceral membrane of thelung, the device comprising: a conduit adapted for insertion intoparenchymal tissue of the lung through the visceral membrane of the lungin order to allow the removal of gasses from the lung; a ring receivedaround the conduit; said ring having a pre-implantation configuration inwhich the ring is positioned such that a portion of the visceralmembrane surrounding the aperture is received between the ring and theconduit; and said ring having a post-implantation configuration in whichthe ring radially compresses the visceral pleura against the conduit tocreate a seal between the visceral pleura and the conduit.
 17. Thedevice of claim 16 wherein said ring comprises a super elastic material.18. The device of claim 16 wherein said ring comprises a shape memorymaterial.
 19. The device of claim 16 wherein said ring comprises abioabsorbable material.
 20. The device of claim 16 wherein said ringcomprises polyglycolic acid.
 21. The device of claim 16 wherein saidring can be manually reconfigured from the pre-implantationconfiguration to the post-implantation configuration.
 22. The device ofclaim 16 wherein said ring includes a pleurodesis agent.
 23. A devicefor treating a lung of a patient through an aperture in a visceralmembrane of the lung, the device comprising: a tube having a distal endadapted for insertion into parenchymal tissue of the lung through thevisceral membrane of the lung; a connector slidingly received around thetube; the tube and the connector defining therebetween an annular spaceadapted to receive a portion of the visceral membrane surrounding theaperture; and wherein the connector is configured such that, with aportion of the visceral membrane received in the annular space, theconnector radially compresses the visceral membrane between theconnector and the tube thereby secure the visceral membrane to the tubeand creating an airtight seal between the tube and the visceralmembrane.